Descripción de la oferta
Leanbio is a leading Biopharmaceutical CDMO offering end-to-end services in the field of recombinant proteins, mRNA and pDNA. With over a decade of expertise, we have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA and pDNA. Leanbio has already worked with over 100 candidates over these years, some already in late clinical stages. Leanbio is expanding its development and manufacturing capabilities with a new GMP site in Barcelona with over 4,000 sqm. and three manufacturing areas: one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third are for mRNA up to 50L. The new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a global service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do: Providing cutting-edge end-to-end services. Offering extensive expertise in biologics. We are looking for a new person to join the team as a DSP Manufacturing Team Leader in our brand new facilities in Sant Quirze del Vallès: MAIN RESPONSIBILITIES: Team Leadership & Development: Supervise and guide DSP technicians and engineers, promoting continuous professional growth through training and problem-solving support. Encourage proactive communication within the team and with other departments to resolve operational issues. DSP Project Management & Cross-Department Collaboration: Plan, coordinate, and execute downstream processing projects, ensuring quality, timelines, and efficiency while collaborating with R&D, QA, QC, and MSAT teams during tech transfers. Manage the integration of new processes or modifications to existing ones, ensuring successful implementation and validation. Process Optimization & Protocol Development: Develop and implement improvements in protein purification processes (centrifugation, filtration, chromatography), and create standardized protocols to enhance yield and reproducibility. Use data-driven approaches to identify process bottlenecks, implement corrective actions, and drive continuous improvements in throughput, yield, and product purity. Regulatory Compliance and Quality Standards: Ensure all DSP operations comply with GMP regulatory standards, maintaining the highest quality and safety in all processes. Regularly review and update standard operating procedures (SOPs) to stay current with evolving industry regulations, internal best practices, and audit findings. Ensure that all data, from batch records to test results, is accurately documented, and that all documentation meet regulatory and quality requirements. Performance Monitoring & Resource Management: Monitor KPIs (e.g., protein yield, cycle time, cost), manage resource allocation effectively, and ensure availability of required equipment to optimize operations. Ensure the availability and functionality of required equipment and reagents, overseeing maintenance schedules and troubleshooting issues in collaboration with the maintenance team. REQUIREMENTS: Bachelor’s degree in biotechnology, Biology, Chemistry, Chemical Engineering, or related fields and master’s degree or specialization in areas related to bioprocessing, protein engineering, or biotechnology. At least 5 years of experience in a GMP manufacturing environment, with a minimum of 2 years in a leadership or supervisory role in downstream processing (DSP) and protein purification. Solid experience in purification techniques such as chromatography, filtration, centrifugation, and other separation techniques. Familiarity with laboratory and production equipment used in DSP, including its operation and maintenance and experience in process optimization and troubleshooting technical issues during purification processes. Knowledge of Good Manufacturing Practices (GMP) principles, regulations, and quality standards in the pharmaceutical or biotechnology industry. Ability to plan, coordinate, and execute DSP projects while ensuring adherence to timelines, costs, and quality standards. Knowledge and experience in regulatory compliance with international standards (FDA, EMA, etc.), particularly within GMP production environments. Fluency in English (both written and spoken) is required, as most technical documentation and regulatory standards are in English. Flexibility in working hours may be needed to accommodate project timelines and cross-departmental collaboration. #J-18808-Ljbffr
